Wearable apparatus for the treatment or prevention of osteopenia and osteoporosis

Information

  • Patent Grant
  • 11806262
  • Patent Number
    11,806,262
  • Date Filed
    Tuesday, December 7, 2021
    2 years ago
  • Date Issued
    Tuesday, November 7, 2023
    6 months ago
Abstract
A wearable apparatus for the treatment or prevention of osteopenia or osteoporosis, stimulating bone growth, preserving or improving bone mineral density, and inhibiting adipogenesis is disclosed where the apparatus may generally comprise one or more vibrating elements configured for imparting repeated mechanical loads to the hip, femur, and/or spine of an individual at a frequency and acceleration sufficient for therapeutic effect. These vibrating elements may be secured to the upper body of an individual via one or more respective securing mechanisms, where the securing mechanisms are configured to position the one or more vibrating elements in a direction lateral to the individual, and the position, tension, and efficacy of these vibrating elements may be monitored and/or regulated by one or more accelerometers.
Description
FIELD OF THE INVENTION

The present invention relates generally to the stimulation of bone growth, healing of bone tissue, and treatment and prevention of osteopenia, osteoporosis, and chronic back pain, and to preserving or improving bone mineral density, and to inhibiting adipogenesis particularly by the application of repeated mechanical loading to bone tissue.


BACKGROUND OF THE INVENTION

Low bone mineral density (BMD) and osteoporosis are significant problems facing the elderly, leading to 1.5 million fractures in 2002 (National Osteoporosis Foundation (NOF): America's bone health: The state of osteoporosis and low bone mass in our nation. Washington DC, National Osteoporosis Foundation, 2002). Bisphosphonates, a class of compounds that generally inhibit the digestion of bone, have been used for over a decade to treat osteoporosis with significant success but cause unwanted side effects including osteonecrosis of the jaw, erosion of the esophagus, and atypical femoral fractures, which has lead to the reconsideration of the use of bisphosphonate therapy.


One alternative to treat osteoporosis has been the use of Whole Body Vibration (WBV), which consists of repeated mechanical loading of bone tissue through vibration devices, using relatively high frequencies (e.g. 15-90 Hz) and relatively low mechanical loads (e.g. 0.1-1.5 g's). Studies have shown that WBV can delay and/or halt the progression of osteoporosis (Rubin et. al., Journal of Bone and Mineral Research, 19:343-351, 2004). In another randomized study, in which ≥0.6 g's of vibratory force were delivered to the feet of the patient, it was demonstrated that WBV was effective in improving hip BMD outcomes as compared to control groups that either did not exercise or were part of an exercise program (Verschueren et al., Journal of Bone and Mineral Research, 19:352-359, 2004).


Related studies have demonstrated the ability of WBV to improve hip and preserve spine BMD in populations of healthy cyclists, postmenopausal women and disabled children (Am J Phys Med Rehabil 2010; 89:997-1009, Ann Intern Med 2011; 155:668-679, J Bone and Mineral Research 2011; 26(8):1759-1766).


The mechanism by which WBV influences BMD is an issue of some debate but studies have suggested that the shear stress within bone marrow in trabecular architecture during high frequency vibration could provide the mechanical signal to marrow cells that leads to bone anabolism (Journal of Biomechanics 45(2012):2222-2229). More specifically, shear stress above 0.5 Pa is mechanostimulatory to osteoblasts, osteoclasts and mesenchymal stem cells (Journal of Biomechanics 45(2012):2222-2229).


Many conventional methods of promoting bone tissue growth and bone maintenance by the application of WBV generally tend to apply relatively high frequency (e.g. 15-90 Hz) and relatively low magnitude mechanical loads (e.g. 0.1-1.5 g's) to bodily extremities, such as the use of vibrating platforms upon which a user stands that apply repeated mechanical loads to the feet of a user. Current WBV vibration platforms (e.g. Galileo 900/2000™, Novotec Medical, Pforzheim, Germany; or Power Plate™, Amsterdam, The Netherlands) and associated treatment regimens require the user to stand on a platform for up to 30 minutes a day, which is inconvenient for many users. Furthermore, applying vibration to the feet of the patient is an inefficient method for mechanically loading the hips, femur, and spine, the targeted areas for WBV therapy for osteoporosis. Up to 40% of vibration power is lost between the feet and the hips and spine due to mechanical damping in the knees and ankles (Rubin et al., Spine (Phila Pa 1976), 28:2621-2627, 2003).


One other issue with current WBV platforms is the directionality of applied force. Standing on a vibrating platform, an individual receives WBV stimulus in a plane perpendicular to the spine and long bones of hip. Studies have shown that vibrations applied “in the inferior-superior direction would be misaligned with the principal trabecular orientation in the greater trochanter and femoral neck, resulting in lower shear. In contrast, trabeculae in the lumbar spine are aligned with the direction of vibration and the permeability is higher (Journal of Biomechanics 45(2012):2222-2229).


There is a need for a more efficient and easy to use source of mechanical vibration that delivers 0.6 g+/−0.5 g of force directly to the spine and hips. A more efficient method for delivering vibration force would be to reduce the load applied to the patient and make the device easier to use, while maximizing therapeutic benefit to osteoporosis by localizing the repeated mechanical loads delivered to the hip and spine. Additionally, the potential to deliver WBV in a plane parallel to the directionality of the spine and long bones of the hip may be more beneficial than a traditional vibrating plate on which a person stands.


Finally, the existing technology of vibrating platforms limits the application of WBV to special populations that may benefit from its use. Cyclists, for example, have been shown to have lower BMD than other athletes and even lower than the BMD of sedentary people (Int J Sports Med 2012; 33:593-599). Thus, a wearable delivery system for this technology extends the reach of this tool to a wider population of individuals. Not only could a wearable device be used during cycling (or other activities), the present invention could be adapted to deliver WBV through a bicycle to the rider for the purpose of preserving BMD in cyclists.


In a separate but connected issue, WBV have been suggested to be “anabolic to the musculoskeletal system” and “in parallel, suppress adiposity” (PNAS. Nov. 6, 2007; 104(45):17879-17884). In animal models, studies have shown that low magnitude WBV can reduce stem cell adipogenesis and can provide a tool for “nonpharmacologic prevention of obesity and its sequelae” (PNAS. Nov. 6, 2007; 104(45):17879-17884). In a study done with obese women, WBV displayed a “positive effect on body weight and waist circumference reduction” (Korena J Fam Med. 2011; 32:399-405).


SUMMARY OF THE INVENTION

The present invention seeks to provide a novel method and apparatus for the stimulation of bone growth, healing of bone tissue, and prevention of osteoporosis, osteopenia, and chronic back pain, as is described more in detail hereinbelow. The present invention may maintain or promote bone-tissue growth, may prevent the onset of osteoporosis, and may treat chronic back pain.


Contrary to the prior art, which attempts to induce WBV to the subject while standing on a vibration platform or through other application of WBV to bodily extremities, the present invention provides more effective treatment by targeted application of oscillating mechanical loads to the hip and spine of a user, as is described hereinbelow.


What is more, in distinction from the prior art, the present invention allows for delivery of WBV stimulus in side-to-side, front-to-back, and/or in an inferior-superior directions. This flexibility in the delivery system and the potential to load the bones of the spine and hips in more than just an inferior-superior plane (as is the case with a vibrating platform), may allow for better targeting of the hips and spine in the treatment of osteoporosis and loss of BMD. More specifically in one variation, one or more vibrating elements may be positioned against the patient's body via one or more securing mechanisms, respectively, which are configured to position the vibrating elements in a direction lateral to the individual's body such that the mechanical loads are applied laterally to the patient rather than in an inferior-superior direction.


In one aspect of the present invention, a wearable apparatus for treating osteoporosis and supporting BMD is provided, comprising one or more vibrating elements configured for imparting repeated mechanical loads to the hip and spine of an individual at a frequency and acceleration sufficient for therapeutic effect on osteoporosis; and one or more securing mechanisms for securing said one or more vibrating elements to the upper body of said individual; wherein said one or more vibrating elements are configured for applying said repeated mechanical loads to said individual's hip and spine.


In one embodiment of the present invention, the securing mechanisms of the apparatus attach to the shoulders of an individual to apply vibration to the back of the individual. In another aspect, additional securing mechanisms attach to the waist of the individual to provide additional support to the apparatus while it applies vibration to the back of the individual. In another embodiment, the securing mechanisms attach only to the waist or hips of an individual to apply vibration in those locations. The location of applied vibration can thus be adjusted to preferentially deliver vibration to the spine, hips, or other locations.


In another aspect of the present invention, the device is worn around the waist of the individual such that the vibrating element delivers vibration to the lower abdomen or lower back of the individual. This placement maximizes the transmission of vibration to both the spine and the hip.


In another aspect of the invention, the device can be configured to be worn around other parts of the body, including extremities such as the arms, legs, hand, feet, and head. This configuration is preferably a scaled-down version of the embodiment to be worn around the spine, waist, or hips.


In another embodiment, the apparatus further comprises a manually settable control for adjusting the frequency of said repeated mechanical loads provided by said one or more vibrating elements. In another embodiment, the apparatus further comprises a manually settable control for adjusting the peak acceleration provided by said one or more vibrating elements.


In another embodiment, the peak acceleration is adjustable based on closed-loop feedback from accelerometers around the patient's hips, spine, or other sites of interest. The vibrating elements are programmed to slowly increase the acceleration until the desired level is reached, then maintain that level for the rest of the treatment. In another aspect, the accelerometers are disposable, which ensures performance and provides a recurring revenue stream for the company. In another aspect, the accelerometers are permanently mounted inside the pack itself.


In another embodiment, the relative readings of the various accelerometers ensure that the device is properly positioned and/or tensioned.


In another embodiment, the straps of the pack have force/tension sensors in order to ensure the patient has securely attached the device before beginning treatment.


In another embodiment, said vibrating element comprises an oscillating element energized by an electrical power source. In another embodiment, said oscillating element comprises an oscillating mass that moves in a periodic motion. In another embodiment, said vibrating element vibrates at a frequency in a range of about 15-90 Hz. In another embodiment, said vibrating element generates peak acceleration in a range of about 0.1-1.5 g. In another embodiment, said vibrating element is operative to induce strain in bone tissue in a range of about 1-500 microstrain. In another embodiment, said vibrating element is operative to induce strain in bone tissue in a range of about 20-50 microstrain.


In another aspect of the invention, the pack has an internal timer that tracks the length of treatment and automatically turns the device off after the treatment is complete. This feature can also be used to prevent excessive use of the device.


In another embodiment, the pack has internal memory which is used to log the use of the device. Additionally, the pack has wired and/or wireless connectivity to other devices that can communicate with the patient, the patient's family, and/or the patient's doctor. The other devices can be computers, phones, tablets, watches, or any other similar device capable of displaying and sensing information. Logging information can be used to track compliance and provide reminders to the patient when it is time for a treatment session. This information can also be used as part of a points-base rewards system to encourage the patients to use the device.


In another aspect of the present invention, a method for treating osteoporosis is provided, comprising securing one or more vibrating elements to the upper body of an individual, wherein said one or more vibrating elements are configured to impart repeated mechanical loads to the hip and spine of said individual at a frequency and acceleration sufficient for therapeutic effect on osteoporosis; and wherein said one or more vibrating elements may impart said repeated mechanical loads during said individual's ambulation.


One embodiment of the present invention would include a mechanism for delivering WBV through a bicycle to the rider for the prevention of osteoporosis and supporting BMD.


Additionally, the present invention provides a wearable tool to use WBV for the purpose of weight loss and decreasing adipogenesis.


INCORPORATION BY REFERENCE

All patents, patent applications, and other publications referred to herein are expressly incorporated by reference, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. All documents cited are, in relevant part, incorporated herein by reference. However, the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention.





BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:



FIG. 1 is an illustration of an exemplary embodiment of the present invention from an angled rear perspective.



FIG. 2 is an illustration of an exemplary embodiment of the present invention with two vibrating elements from the rear perspective.



FIG. 3 is an illustration of an exemplary embodiment of the present invention from an angled rear perspective.



FIG. 4 is a graph illustrating the ability to preferentially apply vibration to the spine or hips depending on where the present invention is worn.



FIGS. 5A and 5B are graphs illustrating accelerations experienced at the hip and lumbar spine during normal use of the present invention.



FIG. 6 is a plot demonstrating the ability of the present invention to automatically adjust the magnitude of acceleration based on accelerometer feedback.



FIG. 7 is a picture of a preferred embodiment of the present invention and its components.





DETAILED DESCRIPTION OF THE INVENTION

The present invention provides methods and apparatuses for the stimulation of bone growth, healing of bone tissue, and treatment and prevention of osteopenia, osteoporosis, and chronic back pain.


Exemplary embodiments of the apparatus of the present invention are illustrated in FIGS. 1-7 as follows.



FIG. 1 illustrates an apparatus for the stimulation of bone growth, prevention of osteopenia, healing of bone tissue, and treatment and prevention of osteopenia, osteoporosis, and chronic back pain 10, constructed and operative in accordance with an embodiment of the present invention. The apparatus 10 may include a vibrating element configured for imparting repeated mechanical loads to the hip and spine of an individual at a frequency and acceleration sufficient for therapeutic effect on osteoporosis 12. The vibrating element 12 may be secured to the upper body of an individual through one or more securing mechanisms 14. In such an arrangement, the vibrating element 12 may be configured for applying repeated mechanical loads to an individual's hip and spine.


Securing mechanisms 14 may be constructed in any shape and of any suitable material. For example, the securing mechanisms 14 may be made of any elastomeric material, such as but not limited to, cloth, woven or non-woven, natural or synthetic rubber, silicone rubber, polyurethane, nylon, or polyester, with one or more enclosures for containing the vibrating element 12. The securing mechanisms 14 may be in the form of a vest and may include one or more sleeves or shoulder straps for the upper extremities of the subject. The securing mechanisms may fasten the vibrating element 12 to the torso of an individual in any manner, such as but not limited to, VELCRO, hooks, buckles, buttons, zippers, tying (e.g. laces), adhesive, and the like. The securing mechanisms may also attach to the shoulders, chest, abdomen, waist, hips, arms, legs, hands, feet, or head of an individual. The vibrating element 12 does not have to be contained within an enclosure, and may be attached in any other manner to the securing mechanisms 14, such as but not limited to, by bonding, embedding, etc. The securing mechanisms 14 may have any length, width and thickness.


Optionally, electronics may be embedded in the apparatus such that the electronics enable communication between the apparatus and another device (e.g., a server, computer, communications device, smart phone, etc.) which may be remotely located. The electronics may be configured to track and/or report compliance with a prescribed or recommended usage through wired or wireless protocols for reporting or communicating with the other device.


The vibrating element 12 may be configured for imparting repeated mechanical loads through any means known in the present art. The vibrating element 12 may include an oscillating element energized by an electrical power source. For example, an electromagnetic weight may be attached to a spring which is mounted for oscillating motion inside the vibrating element 12 and alternately attracted and repelled by a surrounding frame made of ferrous material, that is, an oscillating mass that moves in a periodic motion. It is understood that this is just one example of the vibrating element 12 being energized by an electrical power source 16. Another example of a vibrating element is an ultrasonic transducer that induces vibration of desired amplitude. Yet another example of a vibrating element is a slider-crank mechanism (e.g. as described in Zhang, Y. “Introduction to Mechanisms”, Carnegie Mellon University). Yet another example of a vibrating element is an eccentric mass attached to a motor that creates vibrations as it rotates.


The vibrating element may also be configured to impart repeated mechanical loads in such a way that the frequency and amplitude of acceleration are decoupled. In one embodiment, the vibrating element makes use of a clutch mechanism which is able to adjust the amplitude of the acceleration while the frequency remains constant. In another embodiment, the element makes use of a motor and eccentric weight attached to an adjustable-length moment arm. By adjusting the length of this moment arm, the amplitude of the acceleration can be adjusted independently of the frequency. In yet another embodiment, multiple eccentric motors are used and designed to have interference that is either constructive, destructive, or mixed. Depending on the setting, the motors are either be in phase, out of phase, or somewhere in between, which allows the amplitude of the acceleration to be adjusted while maintaining a constant frequency.


The vibrating element 12 may be configured for imparting repeated mechanical loads to the hip and spine of an individual at a frequency of between about 1-200 Hz and a peak acceleration of between about 0.1-10 g (where g=9.8 m/s) to induce strain in bone tissue of an individual in a range of about 1-500 microstrain. Alternatively, the vibrating element 12 may vibrate at a frequency in a range of about 1-100 Hz, about 1-50 Hz, about 5-35 Hz, about 20-50 Hz, or about 15-45 Hz. Alternatively, the vibrating element 12 may impart repeated mechanical loads at a peak acceleration of between about 0.1-5 g, about 0.3-1.5 g, about 0.6-1.5 g, or about 0.6 g. Alternatively, the vibrating element 12 may induce strain in bone tissue in a range of about 50-500 microstrain, about 1-250 microstrain, about 1-100 microstrain, or about 100 microstrain. However, the present invention is not limited to these values and other ranges of amplitude and frequency may be used.


The frequency of the applied repeated mechanical loads provided by the vibrating element 12 may be adjusted by an individual by a manually settable control. Alternatively, the peak acceleration of repeated mechanical loads imparted by the vibrating element 12 may be adjusted by an individual by a manually settable control. The vibrating element 12 may be capable of being adjusted to any value or range of frequency or peak acceleration as desired. The manually settable control may be in the form of a rotating dial, one or more push buttons, one or more switches, or a computer interface. Additionally, the vibrating element 12 may be suitably comfortable enough for patients to wear up to 10 minutes (or longer) at a time.


The electrical power source 16 may be a battery (which may be rechargeable) disposed in the vibrating element 14. Alternatively, the electrical power source 16 may be external to the apparatus 10, such as but not limited to, AC power or other power supply, and may be in wired (e.g., connected by an electrical range cord or any other kind of electrical connector or terminal) or wireless (e.g., radio frequency (RF), infrared, laser, Bluetooth, etc.) communication with the vibrating element 12. In the case of a battery, a status LED or other means of alert can be used to inform the user when the battery needs to be replaced or charged.



FIG. 2 illustrates the apparatus 10 with multiple vibrating elements 12. The apparatus 10 may contain one, two, three, four, five, or more than five vibrating elements 12.



FIG. 3 illustrates the apparatus 10 with securing mechanisms 14 that attach only to the waist or hips of an individual. This embodiment still comprises at least one vibrating element 12 and electrical power source 16.



FIG. 4 illustrates the ability to preferentially deliver vibration to the spine, hips, or other locations, depending on where the present invention is worn. The data were collected by attaching accelerometers to the skin directly superficial to the iliac crest (hip) and T7 vertebra (spine) of a test subject, while the present invention was worn on the back, waist and hips of the subject. When worn on the back, vibrations are preferentially delivered to the spine of the individual. When worn on the hips, vibrations are preferentially delivered to the hips of the individual. When worn on the waist, vibrations are preferentially delivered to the spine of the individual, although significant vibrations are also delivered to the hip. Therefore, the preferred embodiment of the present invention is to be worn around the waist of an individual. More specifically, the invention should be placed over the lower abdomen and lower back to maximize transmission of vibration to both the spine and the hip.



FIG. 5A further illustrates the accelerations experienced at the hip and lumbar spine during normal use of the present invention. With the device properly positioned, acceleration magnitudes of around 0.6 g are delivered, as measured by skin-mounted accelerometers.


The present invention may stimulate bone growth, maintain bone tissue, preserve or improve bone mineral density, and prevent osteoporosis and osteopenia in various bone regions of the hip (e.g. femoral head, femoral neck, greater trochanter, lesser trochanter, femur, anterior superior iliac spine, etc.) and spine (e.g. cervical spine, thoracic spine, lumbar spine, sacrum, coccyx, etc.). Alternatively, the present invention may stimulate bone growth in bones in other parts of the body, as the vibrations carry to other parts of the body (e.g., bones in the vicinity of the legs, knees, or feet). Stimulation to other sites can also be accomplished by using a scaled-down version of the present device to directly stimulate the legs, arms, feet, hands, head, or any other location.


In order to determine the vibration levels that the patient receives when wearing the apparatus 10, accelerometers may be used with the patient. For instance, bone-mounted accelerometers may be used although invasive to the patient.


Alternatively, the present invention may also make use of feedback from accelerometers (e.g., triaxial accelerometers with a range of +/−3 g such as ADXL335, Analog Devices) to adjust the amplitude of acceleration delivered to the patient. These accelerometers (which are in communication with a processor, not shown) may be between the vibrating element 12 and user's skin or in proximity to the vibrating element 12. Once the accelerometers are secured, the peak-to-peak acceleration may be measured or monitored at, e.g., the hip (superficial to the right iliac crest) and lumbar spine (first lumbar vertebra), along areas of the skin not covered by the device and optionally wrapped tightly with elastic bandages to secure the attachment. An example of an accelerometer 17′ which may be used with the apparatus is illustrated in FIG. 3. While a single accelerometer 17′ is shown, multiple accelerometers may be utilized if so desired. Moreover, the user of accelerometers 17′ may be utilized with any of the apparatus variations as described herein. FIG. 5B illustrates the accelerations experienced at the hip and lumbar spine using the accelerometers.


When turned on, the device can adjust the acceleration to the desired level and maintain it during the course of the treatment. This feature also allows for self-correcting of the pack if the straps loosen, the patient changes posture, or any other event that may impact the acceleration felt by the patient. Alternatively, the accelerometers may be a permanent part of the device. Though not as accurate as accelerometers secured directly to the skin, this method still provides useful information about the acceleration magnitude and can also be used for feedback control. An illustration of this is shown in FIG. 3, which has two pack-mounted accelerometers 17.



FIG. 6 shows a plot that demonstrates the ability of the present invention to adjust the magnitude of the acceleration based on accelerometer-based feedback. At 60 seconds, the device is loosened such that the acceleration delivered to the patient has been diminished. At 150 seconds, the device automatically adjusts to the loosening by increasing the magnitude of the acceleration until it has returned to the pre-loosening level.


The present invention may also make use of force or tension sensors embedded in/on securing mechanisms 14. These sensors can provide feedback about the snugness of the device against the patient, which affects the efficiency of acceleration transmission. Preferably, the device provides an alert if the securing mechanisms are too loose, whether initially or due to loosening during a treatment session.


A preferred embodiment of the present invention is shown in FIG. 7, which illustrates the components that comprise the device. Components of the wearable vibration device include the waist-pack housing A, padding B, motor housing C, battery D, eccentric weights E, DC motor F, surface mount electrodes G, and computer chip with control software H.


The method and apparatus of the present invention enable the treatment and prevention of osteoporosis in an individual in a standing, seated or any other upright static posture, as well as during ambulation or any other activities of daily living, such as driving a car, driving an electric wheelchair, or riding a train. Other advantages provided by the method and apparatus of the present invention include the direct application of repeated mechanical loads to the bones most at risk for fracture in osteoporosis, and bypassing the unnecessary mechanical loading of the feet or knees as is done in vibrational platforms. Another advantage of the method and apparatus of the present invention is that little or no training/learning is required of an individual to utilize the present invention.


Additionally, the present invention provides the advantage of having the potential to deliver vibration stimulus to the spine and hips in more than just an inferior-superior direction (but also transverse, or side-to-side, and front-to-back directions).


Although the present invention has been described with respect to preferred embodiments, it will be readily apparent to those having ordinary skill in the art to which it appertains that changes and modifications may be made thereto without departing from the spirit or scope of the disclosure.


What is more, the wearable nature of the present invention provides for portable and battery-powered delivery systems for WBV, an issue not contemplated in the current state of the art for vibration treatment systems.


In addition, one embodiment of the present invention would include a mechanism for delivering WBV through a bicycle (e.g. stem, seat, pedals, handlebars) to support/preserve BMD in cyclists.


Additionally, the present invention is intended to be used for the purpose of providing a wearable tool for weight loss, decreasing waist circumference and decreasing adipogenesis.


The applications of the devices and methods discussed above are not limited to the treatment of bone loss but may include any number of further treatment applications. Moreover, such devices and methods may be applied to other treatment sites within the body. Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.

Claims
  • 1. A wearable apparatus for treating or preventing osteoporosis or osteopenia, comprising: one or more vibrating elements configured for imparting repeated mechanical loads to a hip of an individual at a frequency and acceleration sufficient for therapeutic or preventative effect on osteoporosis or osteopenia;one or more securing mechanisms for securing said one or more vibrating elements to the body of said individual,wherein said securing mechanisms are configured to wrap the apparatus around the waist or torso of the individual, andwherein the one or more vibrating elements are secured to the body such that vibrations from the repeated mechanical loads are carried through the body to bones beyond the hip.
  • 2. The apparatus of claim 1, further comprising an electronics assembly in communication the one or more vibrating elements.
  • 3. The apparatus of claim 2, further comprising a timer in communication with the electronics assembly and where the timer is configured to track a length of a treatment.
  • 4. The apparatus of claim 3, wherein the timer is further configured to automatically stop the treatment upon completion.
  • 5. The apparatus of claim 2, wherein the electronics assembly is further configured to log a use of the apparatus by the individual.
  • 6. The apparatus of claim 5, wherein the electronics assembly is further configured to determine whether the use by the individual complies with a prescribed or recommended use.
  • 7. The apparatus of claim 2, wherein the electronics assembly is further configured to provide one or more treatment session reminders to the individual.
  • 8. The apparatus of claim 2, wherein the electronics assembly is further configured to connect wirelessly with a device of another party.
  • 9. The apparatus of claim 8, wherein the device of the other party is configured for use by a doctor, a patient, or a family member.
  • 10. The apparatus of claim 1, further comprising one or more accelerometers configured to be positioned over the hip of the individual when the wearable apparatus is worn and are configured to measure acceleration at the hip of the individual.
  • 11. The apparatus of claim 1, further comprising one or more accelerometers configured to be positioned in a location other than the hip of the individual when the wearable apparatus is worn, wherein the one or more accelerometers are configured to measure acceleration at the location other than the hip of the individual.
  • 12. The apparatus of claim 1, wherein the one or more vibrating elements comprises an oscillating eccentric element energized by an electrical power source.
  • 13. The apparatus of claim 1, wherein the one or more vibrating elements vibrates at a frequency in a range of about 15-45 Hz.
  • 14. The apparatus of claim 1, wherein the one or more vibrating elements are secured to the body such that the vibrations are carried throughout a remainder of the body beyond the hip.
  • 15. The apparatus of claim 1, wherein the repeated mechanical loads are applied to the hip such that vibrations are imparted in an inferior- superior direction and a front-to-back direction.
  • 16. The apparatus of claim 1, further comprising a padding layer positionable in contact with a motor in communication with the one or more vibrating elements.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation U.S. patent application Ser. No. 17/093,453 filed Nov. 9, 2020 now U.S. Pat. No. 11,219,542 issued Jan. 11, 2002), which is a continuation of U.S. patent application Ser. No. 16/239,305 filed Jan. 3, 2019 (now U.S. Pat. No. 11,026,824 issued Jun. 8, 2021), which is a continuation U.S. patent application Ser. No. 14/736,077 filed Jun. 10, 2015 (now U.S. Pat. No. 10,206,802 issued Feb. 19, 2019), which is a continuation of International Application No. PCT/US2013/074296 filed Dec. 11, 2013, which claims the benefit of priority to U.S. Provisional Patent Application Nos. 61/797,844 filed Dec. 17, 2012 and 61/873,246 filed Sep. 3, 2013, each of which is incorporated herein by reference in its entirety. This application is further related to U.S. Provisional Patent Application Nos. 61/464,619 filed Mar. 7, 2011 and 61/744,030 filed Sep. 17, 2012; U.S. patent application Ser. No. 13/414,011 filed Mar. 7, 2012 and Ser. No. 13/414,307 filed Mar. 7, 2012; and International Application Nos. PCT/US2012/028071 filed Mar. 7, 2012 and PCT/US2012/069262 filed Dec. 12, 2012, each of which is incorporated herein by reference in its entirety.

US Referenced Citations (124)
Number Name Date Kind
200847 Schmitz Mar 1878 A
200850 Woods Mar 1878 A
3326207 Egan Jun 1967 A
4077394 Mccurdy Mar 1978 A
4413633 Yanda Nov 1983 A
4502490 Evans et al. Mar 1985 A
4570927 Petrofsky et al. Feb 1986 A
4600015 Evans et al. Jul 1986 A
4712566 Hok Dec 1987 A
4841981 Tanabe et al. Jun 1989 A
5035231 Kubokawa et al. Jul 1991 A
5048532 Hickey Sep 1991 A
5158529 Kanai Oct 1992 A
5171299 Heitzmann et al. Dec 1992 A
5220927 Astrahan et al. Jun 1993 A
5240675 Wilk et al. Aug 1993 A
5344435 Turner et al. Sep 1994 A
5389217 Singer Feb 1995 A
5398692 Hickey Mar 1995 A
5413558 Paradis May 1995 A
5425362 Siker et al. Jun 1995 A
5427114 Colliver et al. Jun 1995 A
5431628 Millar Jul 1995 A
5433216 Sugure et al. Jul 1995 A
5478329 Ternamian Dec 1995 A
5570671 Hickey Nov 1996 A
5865801 Houser Feb 1999 A
5902248 Millar et al. May 1999 A
5916153 Rhea, Jr. Jun 1999 A
5921935 Hickey Jul 1999 A
6001600 Hodgson et al. Dec 1999 A
6083215 Milavetz Jul 2000 A
6149578 Downey et al. Nov 2000 A
6287253 Ortega et al. Sep 2001 B1
6434418 Neal et al. Aug 2002 B1
6447462 Wallace et al. Sep 2002 B1
6602243 Noda Aug 2003 B2
6616597 Schock et al. Sep 2003 B2
6648906 Lasheras et al. Nov 2003 B2
6666828 Greco et al. Dec 2003 B2
6866644 Kost Mar 2005 B1
6912416 Rosenblatt Jun 2005 B2
6916283 Tracey et al. Jul 2005 B2
6918924 Lasheras Jul 2005 B2
6931276 Streng et al. Aug 2005 B2
6997884 Ulmsten et al. Feb 2006 B2
7004899 Tracey Feb 2006 B2
7025718 Williams Apr 2006 B2
7052452 Ulmsten et al. May 2006 B2
7112177 Christensen et al. Sep 2006 B2
7252631 Tracey Aug 2007 B2
7255673 Ulmsten et al. Aug 2007 B2
7381190 Sugure et al. Jun 2008 B2
7402144 McLeod Jul 2008 B2
7409240 Bishop Aug 2008 B1
7462158 Mor Dec 2008 B2
7597101 Burnett et al. Oct 2009 B2
7644722 Christensen et al. Jan 2010 B2
7727147 Osorio et al. Jun 2010 B1
7850704 Burnett et al. Dec 2010 B2
7892181 Christensen et al. Feb 2011 B2
7955282 Doo Jun 2011 B2
8052671 Christensen et al. Nov 2011 B2
8273036 Fong Sep 2012 B2
8285399 Van Bommel et al. Oct 2012 B2
8337411 Nishtala et al. Dec 2012 B2
8384907 Tearney et al. Feb 2013 B2
8396537 Balji et al. Mar 2013 B2
9044375 Reyes General Jun 2015 B2
11026824 Burnett et al. Jun 2021 B2
11219542 Burnett et al. Jan 2022 B2
20010020162 Mosel et al. Sep 2001 A1
20010035046 Williams Nov 2001 A1
20020055731 Atala et al. May 2002 A1
20020068860 Clark Jun 2002 A1
20030187392 Egger Feb 2003 A1
20030032904 Grim et al. Sep 2003 A1
20040082859 Schaer et al. Apr 2004 A1
20040097813 Williams May 2004 A1
20040220682 Levine et al. Nov 2004 A1
20040236395 Iaizzo et al. Nov 2004 A1
20050107855 Lennox et al. May 2005 A1
20050216054 Widomski et al. Sep 2005 A1
20050251068 Mor Nov 2005 A1
20060015045 Zets Jan 2006 A1
20060100743 Townsend et al. May 2006 A1
20060135889 Egli Jun 2006 A1
20060189905 Eischen Aug 2006 A1
20060234383 Gouch Oct 2006 A1
20060282175 Haines et al. Dec 2006 A1
20070032733 Burton Feb 2007 A1
20070038143 Christensen et al. Feb 2007 A1
20070203396 McCutcheon et al. Aug 2007 A1
20070237739 Doty Oct 2007 A1
20070255167 Christensen et al. Nov 2007 A1
20080097471 Adams et al. Apr 2008 A1
20080139979 Talish Jun 2008 A1
20080177232 Knighton et al. Jul 2008 A1
20080200847 Bernstein Aug 2008 A1
20080200850 Casalino Aug 2008 A1
20090076573 Burnett et al. Mar 2009 A1
20090112134 Avni Apr 2009 A1
20090187164 Rowe Jul 2009 A1
20090221933 Nishtala et al. Sep 2009 A1
20090308588 Howell et al. Dec 2009 A1
20090312740 Kim et al. Dec 2009 A1
20100030133 Elia et al. Feb 2010 A1
20100099993 Cohen et al. Apr 2010 A1
20100121220 Nishtala May 2010 A1
20100160834 Fong Jun 2010 A1
20100204765 Hall et al. Aug 2010 A1
20100228148 Kim Sep 2010 A1
20110054488 Gruber et al. Mar 2011 A1
20110071482 Selevan Mar 2011 A1
20110118555 Dhumne et al. May 2011 A1
20110144423 Tong et al. Jun 2011 A1
20110301514 Reyes General Dec 2011 A1
20120022415 Mullen et al. Jan 2012 A1
20130023731 Saadat et al. Jan 2013 A1
20130030262 Burnett et al. Jan 2013 A1
20140163439 Uryash Jun 2014 A1
20150328081 Goldenberg et al. Nov 2015 A1
20190133801 Burnett et al. May 2019 A1
20210052407 Burnett et al. Feb 2021 A1
Foreign Referenced Citations (11)
Number Date Country
2683422 Jan 2014 EP
WO 2006060248 Jun 2006 WO
WO 2007018963 Feb 2007 WO
WO 2008097609 Aug 2008 WO
WO 2008103625 Aug 2008 WO
WO 2009055435 Apr 2009 WO
WO 2010141503 Dec 2010 WO
WO 2012056084 May 2012 WO
WO 2012056484 May 2012 WO
WO 2012122267 Sep 2012 WO
WO 2013106155 Jul 2013 WO
Non-Patent Literature Citations (9)
Entry
Addington et al., Intra-abdominal Pressures during Voluntary and Reflex Cough, BioMed Central, Cough 2008, 4:2, Apr. 30, 2008.
Reyes, et al., High-Frequency, Low-Intensity Vibrations Increase Bone Mass and Muscle Strength in Upper Limbs, Improving Autonomy in Disabled Children, Journal of Bone and Mineral Research, 26(8), 1759-1766, 2011.
Rubin et al. Adipogenesis is inhibited by brief, daily exposure to high-frequency, extremely low-magnitude mechanical signals. PNAS. Nov. 6, 2007; 04(45):17879-17884.
Rubin et al., Prevention of Postmenopausal Bone Loss By a Low-Magnitude, High-Frequency Mechanical Stimuli: A Clinical Trial Assessing Compliance, Efficacy, and Safety, Journal of Bone and Mineral Research, 19:343-351, Dec. 22, 2003.
Song et al. Whole Body Vibration Effects on Body Composition in the Postmenopausal Korean Obese Women: Pilot Study. Korena J Fam Med. 2011; 32:399-405.
Verschueren et al. Effect of 6-Month Whole Body Vibration Training on Hip Density, Muscle Strength, and Postural Control in Postmenopausal Women: A Randomized Controlled Pilot Study. Journal of Bone and Mineral Research, 19:352-359, 2004.
Beck et al., The Effect of 8 Mos of Twice-Weekly Low-or Higher Intensity Whole Body Vibration on Risk Factors for Postmenopausal Hip Fracture, American Journal of Physical Medicine 7 Rehabilitation, 89(12): 997-1009, Dec. 2010.
Rubin et al., Transmissibility of 15-Hertz to 35-Hertz Vibrations to the Human Hip and Lumbar Spine: Determining the Physiologic Feasibility of Delivering Low-Level Anabolic Mechanical Stimuli to Skeletal Regions at Greatest Risk of Fracture Because of Osteoporosis. Spine, 28:2621-2627, 2003.
Slatkovska et al. Effect of 12 Months of Whole-Body Vibration Therapy on Bone Density and Structure in Postmenopausal Women. Ann Intern Med., 155(10):668-79, Nov. 15, 2011.
Related Publications (1)
Number Date Country
20220087844 A1 Mar 2022 US
Provisional Applications (2)
Number Date Country
61873246 Sep 2013 US
61797844 Dec 2012 US
Continuations (4)
Number Date Country
Parent 17093453 Nov 2020 US
Child 17544783 US
Parent 16239305 Jan 2019 US
Child 17093453 US
Parent 14736077 Jun 2015 US
Child 16239305 US
Parent PCT/US2013/074296 Dec 2013 US
Child 14736077 US